Ticagrelor Bluefish

Leaflet accompanying the packaging: information for the user

Ticagrelor Bluefish, 60 mg, film-coated tablets

Ticagrelor

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ticagrelor Bluefish and what is it used for
• 2. Important information before taking Ticagrelor Bluefish
• 3. How to take Ticagrelor Bluefish
• 4. Possible side effects
• 5. How to store Ticagrelor Bluefish
• 6. Contents of the packaging and other information

1. What is Ticagrelor Bluefish and what is it used for

What is Ticagrelor Bluefish

Ticagrelor Bluefish contains the active substance ticagrelor. It belongs to a group of medicines called antiplatelet medicines.

What is Ticagrelor Bluefish used for

Ticagrelor Bluefish, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults. The medicine has been prescribed because the patient has had:

• a heart attack, more than a year ago. The medicine reduces the likelihood of another heart attack, stroke, or death due to heart or blood vessel disease.

How Ticagrelor Bluefish works

Ticagrelor Bluefish works by affecting cells called platelets in the blood (also called thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small openings in injured blood vessels.

• a blood clot may completely block the blood flow; this can cause a heart attack (myocardial infarction) or stroke, or
• a blood clot may partially block the blood vessels to the heart; this reduces blood flow to the heart and can cause chest pain that comes and goes (called unstable angina).

Ticagrelor Bluefish helps prevent platelets from clumping together. This reduces the risk of a blood clot forming, which can reduce blood flow.

2. Important information before taking Ticagrelor Bluefish

When not to take Ticagrelor Bluefish

• If the patient is allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• If the patient is currently bleeding.
• If the patient has had a stroke caused by bleeding in the brain.
• If the patient has severe liver disease.
• If the patient is taking any of the following medicines:
• ketokonazole (used to treat fungal infections)
• clarithromycin (used to treat bacterial infections)
• nefazodone (an antidepressant)
• ritonavir and atazanavir (used to treat HIV and AIDS infections). If any of the above situations apply to the patient, they should not take Ticagrelor Bluefish. In case of doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Ticagrelor Bluefish, the patient should discuss it with their doctor or pharmacist if:

• the patient has an increased risk of bleeding due to:
• a recent serious injury
• recent surgery (including dental surgery - the patient should consult their dentist)
• a condition that affects blood clotting
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps).
• the patient will undergo surgery (including dental surgery) while taking Ticagrelor Bluefish. This is because there is an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the planned surgery.
• the patient's heart rate is abnormally low (usually less than 60 beats per minute) and the patient does not have a pacemaker.
• the patient has asthma or other lung diseases or breathing difficulties.
• the patient develops breathing difficulties such as rapid breathing, slow breathing, or shortness of breath. The doctor will decide if further evaluation is needed.
• the patient has any liver problems or has had a disease that could have damaged the liver.
• the patient's blood test shows high levels of uric acid. If any of the above situations apply to the patient, they should talk to their doctor or pharmacist before taking this medicine (or in case of doubt).

If the patient is taking Ticagrelor Bluefish and heparin:

• The doctor may need to take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is essential to inform the doctor about taking both Ticagrelor Bluefish and heparin, as Ticagrelor Bluefish may affect the test result.

Children and adolescents

Ticagrelor Bluefish is not recommended for children and adolescents under 18 years of age.

Ticagrelor Bluefish and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take. This is because Ticagrelor Bluefish may affect the way other medicines work, and other medicines may affect Ticagrelor Bluefish.

• rosuvastatin (a medicine used to treat high cholesterol)
• simvastatin or lovastatin in doses greater than 40 mg per day (medicines used to treat high cholesterol)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control seizures)
• digoxin (used to treat heart failure)
• cyclosporin (used to reduce the body's immune response)
• quinidine and diltiazem (used to treat heart rhythm disorders)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

Particularly, the patient should inform their doctor or pharmacist if they are taking any of the following medicines that increase the risk of bleeding:

• oral anticoagulants, often called blood thinners, including warfarin
• non-steroidal anti-inflammatory drugs (NSAIDs), often used as painkillers, such as ibuprofen and naproxen
• selective serotonin reuptake inhibitors (SSRIs), used as antidepressants, such as paroxetine, sertraline, and citalopram
• other medicines, such as ketokonazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS infections), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches)

The patient should also inform their doctor that, due to taking Ticagrelor Bluefish, there is an increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called clot-busting medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor Bluefish should not be used during pregnancy or if the patient is planning to become pregnant. During treatment with this medicine, women should use adequate contraception to prevent pregnancy.

Before taking this medicine, the patient should inform their doctor if they are breastfeeding. The doctor will discuss the benefits and risks of taking Ticagrelor Bluefish during breastfeeding.

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is unlikely that Ticagrelor Bluefish will affect the patient's ability to drive or use machines. If the patient experiences dizziness or confusion (disorientation) while taking the medicine, they should be cautious when driving or using machines.

Ticagrelor Bluefish contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to take Ticagrelor Bluefish

This medicine should always be taken exactly as the doctor has instructed. If the patient is unsure, they should ask their doctor or pharmacist.

What dose to take

• The usual dose of the medicine is one 60 mg tablet twice a day. The patient should continue taking Ticagrelor Bluefish for as long as their doctor recommends.
• The patient is advised to take the medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Ticagrelor Bluefish with other blood-thinning medicines

The doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance found in many medicines that prevent blood clotting. The doctor will inform the patient about the dose to take (usually between 75 and 150 mg per day).

How to take Ticagrelor Bluefish

• The tablets can be taken with or without food.

What to do if the patient has difficulty swallowing the tablet

If the patient has difficulty swallowing the tablet, they can crush it and mix it with water as follows:

• Crush the tablet into a fine powder.
• Put the powder into half a glass of water.
• Mix and drink immediately.
• To make sure all the medicine is taken, the patient should refill the glass with half a glass of water, rinse, and drink. If the patient is being treated in a hospital, the tablet can be mixed with water and given through a nasogastric tube.

What to do if the patient takes more Ticagrelor Bluefish than they should

If the patient takes more Ticagrelor Bluefish than they should, they should contact their doctor or go to the hospital immediately. They should take the medicine packaging with them. There may be an increased risk of bleeding.

What to do if the patient forgets to take Ticagrelor Bluefish

• If the patient forgets a dose, they should take the next dose at the usual time.
• The patient should not take a double dose (two doses at the same time) to make up for a forgotten dose.

What to do if the patient stops taking Ticagrelor Bluefish

The patient should not stop taking Ticagrelor Bluefish without talking to their doctor. The medicine should be taken regularly and for as long as the doctor recommends. Stopping Ticagrelor Bluefish may increase the risk of another heart attack or stroke, or death due to heart or blood vessel disease.

4. Possible side effects

Like all medicines, Ticagrelor Bluefish can cause side effects, although not everybody gets them.

The patient should contact their doctor immediately if they experience any of the following symptoms - they may need urgent medical attention:

• Bleeding in the brain or inside the skull is an uncommon side effect and may cause stroke-like symptoms, such as:
• -sudden numbness or weakness of the arm, leg, or face, especially if it occurs on one side of the body
• -sudden confusion, difficulty speaking or understanding others
• -sudden difficulty walking, loss of balance or coordination
• -sudden dizziness or severe headache with no known cause
• Bleeding symptoms, such as:
• -heavy or uncontrollable bleeding
• -unexpected or prolonged bleeding
• -pink, red, or brown urine
• -vomiting blood or coffee-ground-like material
• -black or tar-like stools
• -coughing or vomiting blood clots
• Fainting
• -temporary loss of consciousness due to a sudden decrease in blood flow to the brain (frequent)
• Symptoms related to a blood clotting disorder called thrombotic thrombocytopenic purpura (TTP), such as:
• -fever and purple spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme tiredness or confusion.

The patient should discuss the following with their doctor if they experience:

• Shortness of breath (dyspnea) - very common.It may be caused by heart disease or another cause, or it may be a side effect of Ticagrelor Bluefish. Dyspnea associated with Ticagrelor Bluefish is usually mild and characterized by sudden, unexpected shortness of breath, usually at rest, and may occur during the first few weeks of treatment, and may disappear in many people. If the feeling of shortness of breath worsens or persists, the patient should contact their doctor. The doctor will decide if treatment or further tests are needed.

Other possible side effects

Very common (may affect more than 1 in 10 people)

• Increased uric acid levels in the blood (found in laboratory tests)
• Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or lightheadedness
• Diarrhea or indigestion
• Nausea (feeling sick)
• Constipation
• Rash
• Itching
• Increased pain and swelling of the joints - these are symptoms of gout
• Dizziness or lightheadedness or blurred vision - these are symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts and wounds (e.g., while shaving) that is more than usual
• Bleeding from the stomach lining (stomach ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction - rash, itching, swelling of the face or lips/tongue may be signs of an allergic reaction
• Confusion (disorientation)
• Vision problems caused by blood in the eye
• Bleeding from the reproductive tract, which is heavier or occurs at a different time than regular menstrual bleeding
• Bleeding into the joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding, which can cause dizziness or lightheadedness

Frequency not known (cannot be estimated from the available data)

• Abnormally low heart rate (usually less than 60 beats per minute)

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

5. How to store Ticagrelor Bluefish

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Ticagrelor Bluefish contains

• The active substance is ticagrelor.
• Each film-coated tablet contains 60 mg of ticagrelor.
• The other ingredients are:

Tablet core:mannitol (E421), croscarmellose sodium (E468), hypromellose (E464), calcium hydrogen phosphate dihydrate (E341), and magnesium stearate (E572).

Tablet coating:hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b), and iron oxide red (E172).

What Ticagrelor Bluefish looks like and contents of the pack

Ticagrelor Bluefish 60 mg is a round, pink film-coated tablet.

Ticagrelor Bluefish 60 mg is available in blisters containing 14, 56, 60, or 168 film-coated tablets, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden, tel. +46 8 51 91 16 00

Manufacturer/Importer

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: